BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDERMAL FAILSAFE - BANEGAS

    MDR report key: 8286593 · Received January 29, 2019

    Report

    Report Number
    0001822565-2019-00386
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Report Date
    May 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: TCPS SPNDL 38MM STD LNG CATALOG # CP0000209 LOT # 186480, CPS SOFT TISSUE CLLR MED CATALOG # CP0000210 LOT # 948000, TRANSDERMAL TPR ADPTR 92MM CATALOG # CP0000211 LOT # 948810, TRANSDERMAL TPR ADPTR 112MM CATALOG # CP0000212 LOT # 152680, TRANSDERMAL TPR ADPTR PLUG CATALOG # CP0000213 LOT # 950760, TDRML SOFT TIS END CAP CATALOG # CP0000520 LOT # 526520. REPORTED EVENT WAS CONFIRMED BASED ON PHOTOGRAPHS PROVIDED. THERE IS SIGNIFICANT WEAR TO THE TOP PLATE AS CONFIRMED BY THE PHOTOGRAPHS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TDRML FAILSAFE M5 SET SCREW CATALOG # CP0001053 LOT # UNKNOWN, TDRML FAILSAFE TOP PLATE CATALOG # CP0001054 LOT # UNKNOWN, TDRML FAILSAFE BOT PLATE ASY CATALOG # CP0001055 LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMIZED IMPLANTS WERE REQUESTED OF THE SET SCREW, TOP PLATE AND BOTTOM PLATE PROSTHESIS SINCE THE FAILSAFE DISASSEMBLED FROM THE MATING PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78174 TRANSDERMAL FAILSAFE - BANEGAS KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 229550

    Patients

    Seq Age Sex Outcome Treatment
    1